Back to resultsA Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
Primary Purpose
Mycobacterium Avium-Intracellulare Infection, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rifabutin
Sponsored by
About this trial
This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring Rifabutin, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Didanosine (ddI). Patients must have the following: Diagnosis of AIDS as defined by the CDC. Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB). Provide written informed consent. Prior Medication: Allowed: If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry. Required: Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Known hypersensitivity to any of the study drugs. Concurrent Medication: Excluded: Other therapy for mycobacterial disease. Patients with the following are excluded: Known hypersensitivity to any of the study drugs. Prior Medication: Excluded within 4 weeks: Therapy for mycobacterial disease. Antiretroviral drugs, other than zidovudine (AZT) or ddI. Investigational drugs, other than ddI.
Sites / Locations
- Maricopa County Med Ctr
- Bay Harbor Hosp
- Ctr for Special Immunology
- Southwest Community Based AIDS Treatment Group - COMBAT
- AIDS Community Research Consortium
- HIV Research Group
- Davies Med Ctr
- San Francisco Veterans Administration Med Ctr
- Veterans Administration Med Ctr
- TheraFirst Med Ctrs Inc
- Ctr for Special Immunology
- Mem Hosp Hollywood
- Miami Veterans Administration Med Ctr
- Infectious Disease Research Consortium of Georgia
- Dr Frank Rhame
- Research Med Ctr
- North Jersey Community Research Initiative
- Nassau County Med Ctr
- Chelsea Village Med Ctr / Saint Vincent's Hosp
- Dr Alfred F Burnside Jr
- Infectious Disease Physicians Inc
- Milwaukee County Med Complex
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00001995
Brief Title
A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
Official Title
A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
November 1992
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmacia
4. Oversight
5. Study Description
Brief Summary
To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium-Intracellulare Infection, HIV Infections
Keywords
Rifabutin, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rifabutin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Zidovudine (AZT).
Didanosine (ddI).
Patients must have the following:
Diagnosis of AIDS as defined by the CDC.
Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
Provide written informed consent.
Prior Medication:
Allowed:
If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
Required:
Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Known hypersensitivity to any of the study drugs.
Concurrent Medication:
Excluded:
Other therapy for mycobacterial disease.
Patients with the following are excluded:
Known hypersensitivity to any of the study drugs.
Prior Medication:
Excluded within 4 weeks:
Therapy for mycobacterial disease.
Antiretroviral drugs, other than zidovudine (AZT) or ddI.
Investigational drugs, other than ddI.
Facility Information:
Facility Name
Maricopa County Med Ctr
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85010
Country
United States
Facility Name
Bay Harbor Hosp
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Ctr for Special Immunology
City
Irvine
State/Province
California
ZIP/Postal Code
92718
Country
United States
Facility Name
Southwest Community Based AIDS Treatment Group - COMBAT
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
HIV Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Veterans Administration Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
TheraFirst Med Ctrs Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Ctr for Special Immunology
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Mem Hosp Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Infectious Disease Research Consortium of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Dr Frank Rhame
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Research Med Ctr
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032842
Country
United States
Facility Name
Nassau County Med Ctr
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
Country
United States
Facility Name
Chelsea Village Med Ctr / Saint Vincent's Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Dr Alfred F Burnside Jr
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Milwaukee County Med Complex
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8807071
Citation
Dautzenberg B, Castellani P, Pellegrin JL, Vittecoq D, Truffot-Pernot C, Pirotta N, Sassella D. Early bactericidal activity of rifabutin versus that of placebo in treatment of disseminated Mycobacterium avium complex bacteremia in AIDS patients. Antimicrob Agents Chemother. 1996 Jul;40(7):1722-5. doi: 10.1128/AAC.40.7.1722.
Results Reference
background
Learn more about this trial
A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
We'll reach out to this number within 24 hrs